Clinical Research Nurses Research Articles

Perspectives of Oncology Nursing and Investigational Pharmacy in Oncology Research.

This article will provide an overview of the purpose, structure, and function of an investigational pharmacy in oncology clinical research. It will also discuss the role of the oncology nurse in managing investigational drugs (ID) when caring for a patient receiving treatment on a clinical trial and the importance of their role in the trial process. Government regulations, professional guidelines, and best practices. ID management for clinical trials is a multidisciplinary process requiring input from various professionals to ensure safe, accurate, and study-specific administration. The nurse's role in the process of clinical trial ID management is dependent on each institution's expectations of clinical research nurses and the scope of their role. Multiple nursing roles may be involved in caring for patients who are being treated as part of a clinical trial, including clinical research nurses, infusion nurses, or as nurses providing direct patient care (inpatient or outpatient). Providing education on ID management, specific to the nurse's involvement, is a responsibility of the study team. Ensuring proper safeguards, accurate and protocol-specific delivery and documentation of ID, and completion of patient education are key in the conduct of oncology clinical research.

Good Financial Practice and Clinical Research Coordinator Responsibilities.

To describe clinical research billing pitfalls and good financial practices the research nurse coordinator can implement to decrease billing errors in clinical practice. Government websites, published articles, and the author's expertise in national/international research studies. Clinical research billing is a risky business. It involves many steps in the process and requires good communication among all key stakeholders. The clinical research coordinator is the key team player to facilitate good financial practices for research billing. Creating and applying standards, cross-functional transparent communication, and effective processes across the organization can help to increase billing compliance and decreases billing risk to the organization. The research billing process is a critical component of clinical research. However, billing in the process of generating evidence to inform clinical practice is not included in the core competencies in nursing curriculum. As such, in the real world many nurses grapple with taking on the new role of being a clinical research coordinator. Developing knowledge and understanding about the potential billing pitfalls and good financial practices can support clinical research nurses to decrease billing errors and exposure to risk.

The History of Clinical Trials Research: Implications for Oncology Nurses.

To discuss the major milestones in the history of clinical research and how these correlate with the role of the clinical research nurse. Government Web sites, published articles, and grey literature. The history of clinical research, drug development, and the regulations has come of age, and as a result clinical oncology research has a more defined scope and purpose. With the Oncology Nursing Society and the International Association of Clinical Research Nurses recognizing the scopes of practice for clinical research nursing, such roles are becoming more prevalent and integrated in oncology. It is vital for all clinical research nurses to understand and adhere to the laws and regulations related to clinical trials and human subject protection. The clinical research nurse must ensure good clinical practice and compliance with the regulations to ensure the integrity of the study. There are different types of clinical research, including behavioral, therapeutic, and nontherapeutic studies, where clinical research nurses must understand the treatments and the drug development process to better serve their patients.

Clinical research nursing and factors influencing success: a qualitative study describing the interplay between individual and organisational leadership influences and their impact on the delivery of clinical research in healthcare.

Clinical research delivery is a term increasingly used to describe the work undertaken to implement studies which explore and test prevention, diagnosis and treatment in healthcare. Such studies range from multi-site clinical trials to single site observational projects. Whilst widely acknowledged as fundamental to effective healthcare, clinical research is complex to deliver and is met with challenges in the busy clinical environment. The perceptions and experiences of Clinical Research Nurses, whose work is central to this agenda, have emerged as important, yet frequently overlooked insights in relation to the potential success of research delivery. Increased understanding of these insights is essential to address the barriers and maximise facilitators to success in clinical research. To better understand how the perceptions and experiences of Clinical Research Nurses relate to potential for success in research delivery. Seven focus groups and two one-to-one interviews (27 participants) were conducted in a large tertiary North East England National Health Service Foundation Trust between March and June 2017. Clinical Research Nurses' described perceptions and experiences of working to co-ordinate and deliver a range of research as individuals, within their teams, throughout the wider organisation, and beyond. Two key elements situated within an overarching theme of leadership emerged as likely to impact on how successfully they were able to practise:• the individual (self-leadership).• the organisation (leadership culture). The framework emerging from this study illustrates a complex interplay between personal attributes and organisational culture, mediated by national strategies and targets associated with the clinical research agenda. When situated within the concept of leadership, it broadens the potential for understanding the underlying issues and increases the range of possible support mechanisms to improve experiences for Clinical Research Nurses. Framing the challenges in this way contributes new knowledge to the dialogue surrounding clinical research delivery.

Commentary: Clinical research nursing and factors influencing success: a qualitative study describing the interplay between individual and organisational leadership influences and their impact on the delivery of clinical research in healthcare.

Commentary: Clinical research nursing and factors influencing success: a qualitative study describing the interplay between individual and organisational leadership influences and their impact on the delivery of clinical research in healthcare.

From Failure to Excellence: A Capa Plan for Improving CIBMTR Data Submission

Topic Significance & Study Purpose/Background/Rationale Transplant centers that maintain membership in the Center for International Blood & Marrow Transplantation Research (CIMBTR) are required to submit clinical treatment and patient outcome data. To ensure data integrity, the CIMBTR performs audits of submitted data. The audit benchmark is to have a data reporting error rate that is less than or equal to three percent (≤3%) on Transplant Essential Data (TED) and other selected forms. Adverse consequences are instituted if repeated audit failures occur. Audits at our center in 2007, 2011, and 2015 all exceeded the CIMBTR benchmark (>3%). Corrective action plans were implemented after each audit; however, they were not fully completed or successful. Methods, Intervention, & Analysis After the third audit failure in 2015, a systemic review of the data reporting process was performed by the BMT Clinical Nurse Specialist, Research Nurse and Data Manager. Deficiencies were identified in numerous areas: inadequate staffing for data management, lack of ongoing training/development of the data manager, lack of retention of critical documents in the shadow charts, infrequent consultation with content experts, poor design of physical space for storage, and conversion from a paper-based medical records system to an electronic medical record (EMR). A comprehensive corrective action/preventive action plan (CAPA) was implemented to improve the data reporting process and decrease the error reporting rate. The following actions influenced a reduction in errors: structured shadow charts; additional data management support, expansive training of a new data manager, robust internal audit process, and re-commitment by medical staff as content experts for disease-based and GVHD reporting. Findings & Interpretation Internal audits demonstrated improvement over the next three years. A formal audit by CIMBTR in 2019 demonstrated an overall audit error rate of less than one percent ( Discussion & Implications We found the focused use of TED form instructions, extensive auditing and real time audit feedback to be beneficial. The key factor of success for improvement in the data reporting process and subsequent decreased error rate was collaborative work of multiple team members from multiple disciplines within the transplant program.

Clinical research nurses' expectations and realities of their role: A qualitative evidence synthesis.

To synthesise the available body of qualitative studies relating to clinical research nurses' experiences of their role. A systematic search of the literature in five databases was undertaken: CINAHL, MEDLINE, EMBASE, PubMed and ProQuest. Thomas and Harden's three-stage approach to thematic analysis was followed using the ENTREQ statement for reporting. Nineteen studies reported in 20 papers (with a total of 232 nurses) were included in the synthesis. Three analytical themes with six subthemes were identified as follows: "identity"; "meeting targets"; and "patient advocate." Clinical research nurses experience isolation, and contributing to this is their perception of nonresearch nurses' lack of understanding for their role. This can result in difficulties when recruiting study participants. Clinical research nurses can experience internal conflict between being a patient advocate and adhering to a trial protocol. Training is needed to help research nurses develop skills to face challenges in order to ensure safe and ethical care is provided to research participants while also ensuring high-quality data collected for the study.

Streamline - Study of Relapse or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML) Using Electronic Medical Records (EMR): First Analysis from a Multicenter, Retrospective Cohort Study

INTRODUCTION: In AML, the ability to target disease-related mutations is an important therapeutic innovation. FMS-like tyrosine kinase 3 (FLT3) mutations (FLT3mut+) are common in AML and confer a negative impact on prognosis. Since FLT3 mutational status can change over the course of the disease and FLT3-targeting therapies may benefit FLT3mut+ patients (pts), FLT3 mutational testing is recommended for R/R AML pts, even if testing was performed at initial diagnosis. As the landscape of FLT3mut+ R/R AML evolves, it is important to understand how the utilization/sequencing of therapies and application of FLT3 mutational testing impacts pts in real-world settings. The objective of this analysis was to examine real-world data from a large, multicenter, collaborative EMR database to learn more about treatment and FLT3 testing patterns in pts with FLT3mut+ R/R AML. METHODS: This retrospective, longitudinal, observational cohort study was designed to describe treatment FLT3 testing patterns in adult (≥18 years) pts in the USA with FLT3mut+ R/R AML. For this analysis, initial diagnosis of R/R AML must have occurred between January 1, 2015 and November 30, 2018. This study focuses on data collected prior to the date of approval of gilteritinib for treatment of FLT3mut+ R/R AML (November 28, 2018). Patients were identified by confirmation of diagnosis of AML, followed by confirmation of FLT3mut+ disease, and then ≥1 R/R event. Data were derived from a consolidated EMR database, which combined data from CancerLinQ and Vector Oncology. Data were extracted through an SQL query and abstracted by clinical research nurses. Descriptive statistics were used to examine potential differences among subsets of pts. RESULTS: In the initial phase, data from 99 pts (52.5% male; n=52) with FLT3mut+ R/R AML were evaluated. The majority of pts were Caucasian (72.7%; n=72) with a median age of 62 years (range: 20-86) at first R/R episode. At the first R/R event, treatment regimens were diverse; a total of 89/99 (89.9%) pts underwent 44 different anticancer therapies and only 10.1% (n=10/99) of pts received best supportive care (BSC). At first R/R, the most common anticancer treatments were cytarabine + fludarabine + idarubicin (29.4%; n=10/34) for pts undergoing high-intensity chemotherapy (HIC) and decitabine (45.4%; n=5/11) for pts undergoing low-intensity chemotherapy (LIC). The percentage of pts receiving FLT3 inhibitors, either as single agent or in combination with chemotherapy, was 33.3% (n=33/99) of the total population (Table). Among pts aged <60 years, 47.7% (n=21/44) were treated with HIC-most commonly with cytarabine + fludarabine + idarubicin (33.3%; n=7/21). Only 4.5% (n=2/44) of pts received LIC and 9.1% (n=4/44) received BSC. In the pts aged ≥60 years, 10.9% (n=6/55) received BSC. A higher proportion of pts aged ≥60 years received HIC +/- FLT3 inhibitors (38.2%; n=21/55) compared with LIC +/- FLT3 inhibitors (25.5%; n=14/55). The most common treatments included cytarabine-usually in combination with fludarabine and/or idarubicin (84.6%, n=11/13)-for HIC, and azacitidine (alone or in combination; 55.6%, n=5/9) for LIC. Approximately 38.2% (n=21/55) of pts aged ≥60 years received a FLT3 inhibitor (alone or in combination with chemotherapy), with midostaurin being the most frequently prescribed (47.6%; n=10/21), followed by sorafenib (38.1%, n=8/21). Although most pts (83.8%; n=83/99) were tested for FLT3 mutations at initial AML diagnosis, the majority of pts were not retested; retest at first R/R was performed in 29.0% (n=9/31) of pts. At first R/R, 22.2% (n=2/9) of pts had a change in FLT3 mutational status (Figure). No significant differences were observed in FLT3 retesting among pts <60 years vs ≥60 years (P=0.456). CONCLUSIONS: During the study period, there was substantial heterogeneity regarding the management of FLT3mut+ R/R AML. A total of 89 pts received 44 different anticancer therapies and approximately one-third of pts received a FLT3 inhibitor (alone or in combination) at first R/R. However, during the study period, approved agents for treatment of FLT3mut+ R/R AML were not available. Despite NCCN guidelines, at first R/R, FLT3 retesting was not often performed. With recent approval of FLT3-targeted therapies, it is important to measure rates of retesting in the R/R setting to better understand how elements of pt care, such as monitoring changes in FLT3 mutational status, may impact pt outcomes. Disclosures Zeidan: Ariad: Honoraria; Agios: Honoraria; Novartis: Honoraria; Astellas: Honoraria; Daiichi Sankyo: Honoraria; Cardinal Health: Honoraria; Seattle Genetics: Honoraria; BeyondSpring: Honoraria; Medimmune/AstraZeneca: Research Funding; ADC Therapeutics: Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Trovagene: Consultancy, Honoraria, Research Funding; Incyte: Consultancy, Honoraria, Research Funding; Otsuka: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Acceleron Pharma: Consultancy, Honoraria, Research Funding; Celgene Corporation: Consultancy, Honoraria, Research Funding; Jazz: Honoraria; Abbvie: Consultancy, Honoraria, Research Funding; Boehringer-Ingelheim: Consultancy, Honoraria, Research Funding. Gilligan:Astellas: Other: Project. Gautam:Astellas: Other: Project. Hu:Astellas: Other: Project. Grinblatt:Abbvie: Consultancy; Astellas: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Pandya:Astellas Pharmaceuticals: Employment.

Clinical Digest

Sinéad Kelly O'Flynn, Clinical Research Nurse, Cork, Ireland, provides a brief overview of recently published articles on wound, ostomy and continence care

STRATEGIES AND VECTORS OF THE DEVELOPMENT OF NURSING INVESTIGATIONS

The development of nursing largely associated with the expansion of the functions of nurses is a response to the challenges of professional activity due to the development of technology, improvement of diagnostic and treatment and rehabilitation work, both in primary health care and in medical institutions of the second and third levels. However, the system of training and professional development, the management of medical institutions does not fully take into account these new challenges. To determine the strategies influencing the formation of research competencies among nurses and their development vectors, the authors conducted a survey of 486 nurses and a sociological survey of 80 nurses, reflecting the need for mastering digital skills. Professional competencies of nurses have been established to be in demand, and the management of medical institutions is not focused on motivating them to participate in clinical nursing research. The participation of nurses in clinical research was shown to expand the range of knowledge, contributes to the formation of their communicative and digital competencies, forms leadership skills

CE: Original Research: The Clinical Research Nurse: Exploring Self-Perceptions About the Value of the Role.

The purpose of this qualitative study was to describe CRNs' perceptions of the value of their role. Two focus groups were conducted with a purposive sample of 18 CRNs. An interview guide consisting of eight open-ended items was used. Data analysis used critical elements from Krueger's systematic steps for analyzing focus group data. Five major themes emerged from 168 coded statements contained within the focus group transcripts: comprehensive nursing care of research subjects, training and education of research subjects and staff, contributions to clinical science, unique combination of clinical and critical thinking skills, and CRN practice attributes. Subcategories were also identified. In general, participants felt strongly about the value they added.Clinical research nursing requires the use of a variety of abilities and skills, including critical thinking and problem solving, as well as clinical and research knowledge. The CRNs in this study described incorporating these and other elements into their practice, which they associated with their specialized role. The five themes that emerged help elucidate the importance and utility of including CRNs on research teams. The unique combination of applied research knowledge and expert clinical skills sets the specialty of clinical research nursing apart. The study findings, in particular the five themes, provide an evidence-based framework that will be useful in the development of competencies for CRN specialty practice. In helping to bring research findings to bear on clinical care, the impact of CRNs' practice extends beyond the individual patient to larger patient populations.

1 CE Test Hours: The Clinical Research Nurse: Exploring Self-Perceptions About the Value of the Role.

1 CE Test Hours: The Clinical Research Nurse: Exploring Self-Perceptions About the Value of the Role.

Translation and validation of the Clinical Trial Nursing Questionnaire in Swedish-A first step to clarify the clinical research nurse role in Sweden.

To translate the Clinical Trial Nursing Questionnaire (CTNQ) into Swedish and test it for face and content validity as well as internal consistency and reproducibility using test-retest procedures. In many countries, as in Sweden, a registered nurse can be involved in research by becoming a clinical research nurse. The clinical research nurse plays a pivotal role in clinical studies as a part of the research team. Scales have been developed and used with the objective to clarify the role of clinical research nurses: one of them is the CTNQ. A quantitative cross-sectional design with a test-retest procedure was applied to validate the translated questionnaire. By using a snowball sampling method, relevant participants were identified and 49 registered nurses working in the field of research as clinical research nurses answered the questionnaire on two occasions. An expert panel of three clinical research nurses evaluated the questionnaire for face and content validity. The STROBE checklist for observational research has been followed for presenting the research (see File S1). Face and content validity was agreed upon in the expert panel group. Tests for internal consistency of the CTNQ was calculated and showed a high Cronbach's alpha for both the frequency and importance subscales. The test-retest correlation analysis (reproducibility) also revealed a high correlation coefficient for both subscales. The CTNQ-SWE is a valid and robust instrument in a Swedish version. The instrument can be of importance in assessing the role of clinical research nurses in Sweden in future studies. Use of the CTNQ-SWE in future research can be of value for clarification and professional development of the clinical research nurse role in Sweden. The further use of the CTNQ in Sweden can be of value in understanding the process where licensed nurses make a transition into becoming a clinical research nurse, and to identify needs for customised education.

Engaging Clinical Nurses in Research: Nurses' Experiences Delivering a Communication Intervention in a Behavioral Oncology Clinical Trial.

Despite the recognized need for clinical nurses to engage in the conduct of research, little is known about their research experiences. This article describes the experiences of nurses who delivered the communication intervention in a behavioral oncology clinical trial for parents of adolescents and young adults (AYAs) with cancer. A qualitative thematic analysis was conducted of nurse interveners' (NIs') reflections on their experiences delivering the communication intervention. Ten data-generating questions were developed to guide NIs' reflections. Twelve NIs responded via verbal discussions. Six of these also provided written responses. Overall, nurses' experiences as interveners were powerful and positive, and included time and space to be fully present with patients and families. Nurse interveners identified barriers to their involvement in research related to time constraints, administrative support, physical space to privately conduct the intervention, and difficulties maintaining expertise with the intervention. The importance of ongoing collaboration between nurses, unit staff, leaders, and study teams was corroborated. An unexpected finding was the importance of reflective clinical research.

3194 Workforce Engagement and Resilience (WE-R): A Framework for Innovating Clinical Research Careers

OBJECTIVES/SPECIFIC AIMS: 1.Assess changes in clinical research workforce landscape at Duke 2.Optimize and evaluate efficacy of a tier advancement process for clinical research career progression at Duke 3.Implement CRP engagement as a change management mechanism for workforce innovation METHODS/STUDY POPULATION: We evaluated 857 clinical research positions at Duke to understand changes in the workforce (demographics, numbers in each position and tier) since implementing the tier advancement process in 2016. To understand the efficacy of the tier assessment process, data from a subset of this population (n=84) who underwent the advancement process was examined for success rate. Individual employees and their managers were surveyed to understand their perception of the advancement process and identify areas for improvement. We also describe implementation of multiple mechanisms of community engagement to manage expectations around the tier advancement process and to provide opportunities for employees to self-manage their career planning, including portfolio planning and leadership opportunities. RESULTS/ANTICIPATED RESULTS: Whereas the clinical research workforce has grown by 5.5% since tiering began (2016, n=810; 2018 n=857). Nearly 13% of that growth has been in managerial or senior positions (2016, n=111; 2018 n=127). Distributions across job classifications changed only slightly, representing realignment of positions with study-level responsibilities over department-level responsibilities. Notably, clinical research nurses (CRNC & CRNC Sr.) was the only category including tiered and non-tiered positions to drop overall numbers between 2016 (n = 136) and 2018 (n=115), representing a shift in the workforce from research nurses to research coordinators. General demographics (gender, age) remained largely the same. A total of 359 positions have been hired during this time frame, nearly half of which were entry-level positions (175/359): 47 of these positions represent expansion of the workforce. Of 359 new hires since 2016, 271 currently still work in one of the research roles. Of the 84 employees who underwent the tier advancement process, 84% (43/51) succeeded in tier 2 advancement, 70% (14/20) succeeded in tier 3 advancement (CRC, CRNC, and regulatory coordinators), and 77% (10/13) of research program leaders (RPLs) succeeded in achieving tier two, which is the highest tier for this group. Fifty-five employees (65%) and 32 managers responded to a voluntary feedback survey. Overall confidence in the process improved in both groups from 2016 to 2018, most notably with managers. Both groups indicated a 10 hour reduction (employees = 35hr, 2016 and 25hr 2018; managers 25hr, 2016 and 15hr 2018) in time required to complete the tier advancement process. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of objectively-assessed competencies is an important step in the development of a workforce. By 1) maintaining alignment with industry standards for competencies, 2) upholding high standards, and 3) offering a consistent approach to career growth, Duke is working to develop and maintain a workforce that supports high quality research. Since the implementation of standardized job classifications and competency-based tier advancement, the positions have undergone rigorous competency-based needs evaluation. This leads to better matched jobs to study needs as well as increased standardization across the clinical research workforce. We believe that the subtle workforce shifts represent alignment of our positions with the business needs of our clinical research enterprise. Additionally, approximately 15% of our clinical research workforce has taken advantage of the opportunity to advance their own careers. We have made significant improvements in the following tier advancement processes: standardization of assessments, scoring guides, and modes; changes from LMS to a REDCap delivery of the knowledge assessments; streamlined the utilization of electronic documentation; and additional guidance for employees and managers regarding portfolio inclusions. These improvements have increased satisfaction and acceptance with the advancement process and were made possible through strategic communication across the workforce. Regular town hall meetings and focus group feedback sessions have included the clinical research community in discussions of WE-R initiatives and provided a much-needed feedback loop for process improvement and change management. Moreover, inclusion of WE-R discussion in our Research Professional Network events has provided opportunities to discuss career advancement strategies as well as volunteer opportunities to grow and demonstrate leadership competencies.

Preliminary piloting and validation of a questionnaire identifying basic clinical skills practised by research nurses.

Clinical research nurses (CRNs) need to be competent in both clinical and research skills. In the past 10 years there has been increasing focus on developing the research competencies of CRNs. Employers, however, use the nurses' registered status as a proxy measure of clinical competence to perform their duties. The true extent of what clinical skills are practised by CRNs in a large NHS trust is unclear and there is a lack of validated measures to obtain this information. By using a mixed-methods approach of questionnaire and semi-structured interview, we aimed to pilot and validate a questionnaire to identify CRNs' self-reported confidence with clinical skills.

Clinical Research Nursing: Awareness and Understanding Among Baccalaureate Nursing Students

The American Nurses Association recognizes the specialty practice of Clinical Research Nursing, but many new nurses are unaware of the specialty and lack knowledge to effectively interact with research teams. Participants completed a novel online survey to describe the level of awareness and understanding of the clinical research nursing specialty and the effect of clinical studies on nursing practice in fourth-year baccalaureate nursing program students. Ninety-three participants completed the survey. Most were aware that some nurses specialize in the care of clinical study participants, and most did not know how to effectively support research teams. Years of nursing experience was associated with an understanding of how to effectively collaborate with clinical research nurses and an interest in a career as a clinical research nurse. Entry-level nursing programs should expose students to the clinical research nurse role and provide the knowledge needed to collaborate with researchers when caring for patients in clinical studies. [J Nurs Educ. 2018;57(10):598-603.].

CN42 - The Gastrointestinal and Lymphoma Unit lead nurse research role in Royal Marsden Hospital

Background: Clinical research has expanded in many fields with oncology growing vastly in the last 5 years. Specialised nursing and healthcare support is imperative for the smooth operation of the research aspect of a unit, aiming to deliver better care to patients (pts) participating in clinical trials. Methods: Retrospective review of the structure of the Research Clinics between November 2016 and April 2018 in Royal Marsden Hospital in the Gastrointestinal and Lymphoma Unit. Results: The Lead Research Nurse (LRN) structured the team by identifying the complexities involved in running a dedicated Research clinic, developing new roles and assigning the appropriate research team members to support the Clinical Research Fellows. The LRN introduced the role of Assistant Practitioners (APs)who support the running of the clinic by taking vital signs, performing ECG’s and other trial related procedures, such as entering source data into the Electronic Case Report Forms for the sponsor of each clinical study. This has enabled the Clinical Research Nurses (CRN) to spend more time with pts, assessing them for new or existing adverse events, recording concomitant medications, checking blood results, and completing Holistic Needs Assessments at required points throughout treatment. The LRN expanded the role of the Biological Specimen Coordinator (BSC) enabling them to perform phlebotomy on Research pts and take consent for a Translational Research protocol, making their role more hands on and improving retention in this job group. Conclusions: The LRN has a crucial role leading, supervising and developing a split site team consisting of ten CRNs: 5 senior CRNs, 5 junior CRNs, a Translational Research Manager, 5 BSCs and 2 APs. We have achieved a holistic approach for the trial pts whose needs might differ from the usual treatment setting due to the experimental nature of these trials. Our well-structured process has helped pts build better rapport with the team, understanding the importance of all members and various aspects in clinical research. Further training is warranted with Research nurses undertaking advanced practice education, with the view for this model to be adopted in other specialties and institutions. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Developing Interinstitutional Multimodality Model for Translational Studies for Cervical Cancer Screening and Treatment: Pragmatic Issues Pertaining to Logistics, Infrastructure and Solutions

Background and context: Cervical cancer claims the life of 67,500 women every year in India. Persistence of HPV leads to the development of high grade CIN which may progress to invasive cancer. Almost 80% of women are infected with the virus in their lifetime but only a small proportion of women progress to develop cervical cancer. In early cervical cancer patients despite surgery about 25% recur and in advanced cervical cancer about 50%-60% women respond to radiotherapy while the rest progress or recur with disease after standard treatment. The risk to progression and failure to treatment is dependent on both viral/tumor and host factors; therefore an integrated approach should be adopted in developing predictive and prognostic biomarkers to address these clinical questions. Aim: Establishing a clinical and translational research model to provide an infrastructure that will facilitate targeted screening and targeted therapeutics in cervical precancer and cancer. Strategy/Tactics: Integration of various premium institutions in the city with their infrastructure to form a “Systems Medicine Cluster” was established to conduct this research. We have adopted a primary HPV screening (HC2 DNA and genotyping) strategy as a clinical protocol and devised SOPS to enable sample collection strategies for several research usage from the same sample including cytology testing, genomics, metabolomics, microbiome, proteomics. Similarly a translational pathway has been created for seamless tissue collection from cancer patients for multidimensional research usage. Collaboration was established between clinicians, scientists, clinical trial coordinators, research nurses, data managers and biobank personnel to orchestrate this working model. Program/Policy process: Collaboration of various institutions to form a “Systems Medicine Cluster” to effectively implement research strategies for cervical cancer screening and treatment. Outcomes: With the help of translation work we intend to identify of viral and host factors which determine the persistence of the HPV in screened women, thereby risk stratifying them for colposcopic evaluation. In women with cervical cancer who are treated with standard care, we expect to identify modifiable tumor or host factors and drug targets that can be used to reduce the risk of recurrence and improve survival. In 3 months of implementation we have screened 260 women in the cervical cancer screening clinic and obtained samples from 190 cervical cancer patients for translational research. All women have also contributed to the collection of vaginal fluid and blood samples for various research protocols associated with cervical cancer. What was learned: These translational studies conducted hand in hand with clinical pathways requires meticulous planning and teamed approach. The formation of the “Systems Medicine Cluster” with different expertise to address clinical strategies has been a successful model.

Clinical Research Nurse Education: Using Scope and Standards of Practice to Improve Care.

A staff shortage of clinical research nurses leaves a few to cover the jobs of many, and heavy workloads lead to decreased quality care and practices. A new plan of hiring inexperienced nurses was implemented at a comprehensive cancer center to help quickly fill roles; however, challenges arose with training. In response, the research nurse leadership team created a course using the clinical research nursing scope and standards of practice. The results validated the need for this course and supported plans to continue to provide the course to new hires.